Serialisation

Serialisation is the process of assigning unique identifiers to individual medicine packs, enabling track-and-trace capabilities throughout pharmaceutical supply chains from manufacturing through to patient dispensing. This anti-counterfeiting measure, mandated by regulations including the US Drug Supply Chain Security Act and the EU Falsified Medicines Directive, protects patients from counterfeit, stolen, or contaminated medicines whilst providing supply chain visibility that improves inventory management and recall efficiency.

Pharmaceutical serialisation systems generate unique alphanumeric or two-dimensional barcode identifiers for each saleable unit including randomised serial numbers, product identifiers, batch numbers, and expiry dates. These codes are printed on packaging, verified during production, and uploaded to databases tracking products as they move through distributors, wholesalers, pharmacies, and hospitals. The biopharmaceutical industry has invested billions in implementing serialisation infrastructure, upgrading packaging lines with high-speed printing and vision inspection systems whilst developing IT architectures capable of managing massive data volumes. Companies now leverage serialisation data beyond regulatory compliance, using track-and-trace information to optimise supply chains, prevent stockouts, and respond rapidly to quality issues. As counterfeit medicine sophistication increases and supply chains globalise, serialisation provides essential protection for patients whilst enabling companies to demonstrate product authenticity.